Balloon Assisted Maceration Versus Rotational Thrombectomy in Dialysis Access Salvage (BART)

May 18, 2023 updated by: Junaid Yasin Raja, University of Alabama at Birmingham

Pharmacomechanical Dialysis Access Salvage With Balloon Assisted Maceration Versus Rotational Thrombectomy

The purpose of this research study is to compare how well a wire like device disrupts and removes blood clot in your blocked dialysis graft/fistula in comparison to inflating a balloon in your access for the same purpose. The wire like device is called the Cleaner XT and has already been approved by the government/Food and Drug Administration (FDA) for this purpose.

Blood clots in your dialysis access can be fairly common and prevent you from being able to get dialysis. Procedures for opening this blockage must then be performed which is why you have been sent to the hospital today. There are different ways of opening up this blockage which can including blowing up a balloon in multiple areas of the graft/fistula to squeeze the blood clot to break up the blockage or using a wire like device to break up the clot in small pieces and try to remove all of the clot from the wall of the graft/fistula.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • End stage renal disease on hemodialysis
  • Age greater than 18
  • Upper extremity dialysis graft/fistula

Exclusion Criteria:

  • Pregnant
  • Incarcerated
  • Age under 18
  • Inability to consent for self
  • Graft/fistula in a location other than upper extremity
  • Peritoneal dialysis
  • Catheter dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rotational Thrombectomy
Use of the Cleaner XT
Device: Cleaner XT
Wire like device that rotates to allow for wall to wall disruption of thrombus.
Active Comparator: Balloon Assisted maceration
Use of angioplasty balloons for balloon maceration
Device: Balloon
Use of balloon for disrupting thrombus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary patency
Time Frame: 6 months post procedurally
How long the dialysis access remains functional after the procedure.
6 months post procedurally

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Argon Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2023

Primary Completion (Anticipated)

February 29, 2024

Study Completion (Anticipated)

February 29, 2024

Study Registration Dates

First Submitted

March 12, 2023

First Submitted That Met QC Criteria

March 12, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-300010783

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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